Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-04
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Project Support
All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the experimental condition will receive Project Support and be offered case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.
Project Support
The Project Support intervention involves up to four 60-minute individual counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants will receive didactic instruction and feedback on their use of the skills in role-plays with a treatment provider and with their child. In the role-plays the provider first demonstrates how to use the skill in a brief example of typical situations in which the skill could be used. In these examples the caregiver takes on the role of their child and the provider takes on the role of the caregiver. Subsequently the caregiver and provider switch roles so the caregiver has an opportunity to practice executing the skill. The provider helps the caregiver process their experience of each role-play and provides real-time, targeted feedback to help the caregiver develop their ability to use the skills.
Case Management Services
Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.
Treatment as usual
All participants will complete a baseline assessment on demographics, parenting behaviors, and mental health symptoms. Participants randomized to the treatment as usual condition will receive routine provision of case management services. Approximately 4-6 weeks after the baseline assessment all participants will complete a post-test assessment that includes measures of service satisfaction.
Case Management Services
Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.
Interventions
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Project Support
The Project Support intervention involves up to four 60-minute individual counseling sessions focused on teaching caregivers how to listen to and comfort their child. Participants will receive didactic instruction and feedback on their use of the skills in role-plays with a treatment provider and with their child. In the role-plays the provider first demonstrates how to use the skill in a brief example of typical situations in which the skill could be used. In these examples the caregiver takes on the role of their child and the provider takes on the role of the caregiver. Subsequently the caregiver and provider switch roles so the caregiver has an opportunity to practice executing the skill. The provider helps the caregiver process their experience of each role-play and provides real-time, targeted feedback to help the caregiver develop their ability to use the skills.
Case Management Services
Case management services, or treatment as usual, may involve referrals for financial resources or donated goods, as well as assistance with court, law enforcement, or information about orders of protection. The nature of these services depends on the needs identified by the family and case manager. There is currently no standard "treatment" offered to families on the waitlist. This condition will receive individually tailored services, as needed.
Eligibility Criteria
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Inclusion Criteria
* Child is between 6 - 13 years old;
* Caregiver agreed to be contacted for volunteer research opportunities;
* Caregiver and child can communicate in English;
* Child has been living with caregiver for at the last 6 months or longer;
* Family is able to participate in services delivered via telehealth.
Exclusion Criteria
* Child is in Foster Care or Department of Social Services custody;
* The caregiver is unwilling or unable to give informed consent and/or the child is unwilling and unable to give assent.
6 Years
13 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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Caitlin Elizabeth Rancher
Assistant Professor-Faculty
Principal Investigators
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Caitlin Rancher, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Other Identifiers
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Pro00144297
Identifier Type: -
Identifier Source: org_study_id